NOTICE
ANSM - Updated on : 09/02/2022
Product name
PEVARYL 1%, cream
Deconazole nitrate
Box
Please read this leaflet carefully before using this medicine, as it contains important information for you.
You must always use this medicine in strict accordance with the information provided in this leaflet or by your doctor or pharmacist.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist for advice and information.
- If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. See section 4.
- You should contact your doctor if you do not feel any improvement or if you feel less well.
What does this leaflet contain?
1. What is PEVARYL 1% cream and what is it used for?
2. What do I need to know before using PEVARYL 1% cream?
3. How do I use PEVARYL 1% cream?
4. What are the possible side effects?
5. How should PEVARYL 1% cream be stored?
6. Package contents and other information.
1. WHAT IS PEVARYL 1% cream AND WHAT IS IT USED FOR?
Pharmacotherapeutic class: TOPICAL ANTIFUNGAL - IMIDAZOLES AND TRIAZOLES DERIVATIVES, ATC code: D01AC03.
This medicine contains an antifungal agent (active against fungi) of the imidazole family.
It is indicated for the treatment of certain skin mycoses (skin disorders caused by fungi).
Candidiasis :
- Treatment of non-macerated fold mycoses: genital, submammary, interdigital intertrigo, etc.
- Treatment of nail mycoses: onyxis, perionyxis. Associated systemic antifungal treatment is required.
In the case of wool fold infections, oral antifungal treatment is required to treat a possible digestive and/or vaginal focus, and thus avoid any recurrence.
Dermatophytes :
- Treatment :
o Dermatophytes of hairless skin.
o Non-macerated genital and crural intertrigos.
- Treatment of ringworm. Associated systemic antifungal treatment is required.
Erythrasma.
2. WHAT DO I HAVE TO KNOW BEFORE USING PEVARYL 1% cream?
Never use PEVARYL 1% cream:
- if you are allergic to deconazole nitrate or any of the other ingredients listed in section 6.
Warnings and precautions
Talk to your doctor or pharmacist before using PEVARYL 1% cream.
Be careful with PEVARYL 1%, cream:
- in children,
- on large areas of skin,
- on damaged skin,
- in situations where the local docclusion phenomenon may recur (e.g. elderly subjects, bedsores, submammary lesions).
In such cases, it is essential to follow the recommendations and dosage indicated in the package leaflet, as the drug penetrates the skin more easily.
- You should stop using this product if you develop an allergy (recognizable by redness or pimples) or irritation.
- Do not apply to the eyes, nose or mucous membranes in general.
- Candidiasis: do not use soaps with acidic pH (pH favors Candida multiplication).
- This product contains benzoic acid and may cause local irritation. Benzoic acid may increase the risk of dicterus (yellowing of the skin and eyes) in neonates (up to 4 weeks of age).
- This medicine contains butylated hydroxyanisole (E320) and may cause local skin reactions (e.g. contact dermatitis) or irritation of the eyes and mucous membranes.
Children and adolescents
Not applicable.
Other medicinal products and PEVARYL 1%, cream
Tell your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.
Tell your doctor if you are taking a blood-thinning medication, the antivitamins K (such as acenocoumarol, fluindione, warfarin), as PEVARYL may modify the action of antivitamins K in some people. You should therefore monitor your INR (blood tests) frequently. Depending on your situation, your doctor may also decide to modify the dose of your antivitamin K during or after treatment with PEVARYL.
PEVARYL 1% cream with food and drink
Not applicable.
Pregnancy and breast-feeding
In view of the limited but possible systemic passage of PEVARYL after dermal application, and in the light of clinical experience, PEVARYL 1% cream is not recommended for use during pregnancy or while breast-feeding, without the advice of your doctor.
Do not apply to the breasts while breast-feeding.
If you are pregnant or breastfeeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
Driving and use of machinery
Not applicable.
PEVARYL 1% cream contains benzoic acid and butylated hydroxyanisole (E320).
3. HOW DO I USE PEVARYL 1% cream?
Always use this medicine exactly as instructed in this leaflet or as directed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.
Dosage
Apply PEVARYL to the skin 2 to 3 times a day, up to a maximum of 3 applications per day. Treatment should be continued for 2 to 4 weeks.
Method of administration
For EXTERNAL USE ONLY: applied directly to the skin.
1. Clean affected area and surrounding area, then dry skin thoroughly before application.
2. Massage gently and evenly until the cream is completely absorbed.
Regular use of this medication throughout the treatment period is crucial to its success.
If there is no improvement, consult a doctor.
If you have accidentally swallowed PEVARYL 1% cream :
Consult a physician for treatment appropriate to the side effects that may occur.
If you accidentally squirt PEVARYL 1% cream into your eyes :
Wash with clean water or saline solution.
If this does not help, consult a physician.
If you have used more PEVARYL 1% cream than you should have
Not applicable.
If you forget to use PEVARYL 1%, cream
Not applicable.
If you stop using PEVARYL 1%, cream
Not applicable.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, this drug may cause undesirable effects, but they do not occur systematically in everyone.
Common side effects (1 to 10 out of 100 users) are :
- itching,
- burning sensation,
- pain at the application site.
Uncommon adverse reactions (1 to 10 out of 1,000 users) are :
- redness,
- discomfort
- swelling at the application site.
Undesirable effects for which the frequency is not determined are :
- allergy (hypersensitivity),
- swelling of the throat or face (angioedema),
- skin rash,
- urticaria,
- blisters,
- peeling skin (exfoliation).
Reporting side effects
If you experience any side effects, please tell your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. You can also report adverse reactions directly via the national reporting system: Agence nationale de sécurité du médicament et des produits de santé (ANSM) and the network of Regional Pharmacovigilance Centers.
By reporting adverse reactions, you are helping to provide more information on drug safety.
5. HOW SHOULD PEVARYL 1% cream be used?
Keep out of sight and reach of children.
Do not use this medicine after the expiration date indicated on the box. The expiration date refers to the last day of that month.
Store at a temperature not exceeding 25°C.
Do not dispose of any medicine down the drain or in the household waste. Ask your pharmacist to dispose of any medicines you no longer use. These measures will help protect the environment.
6. CONTENTS AND OTHER INFORMATION
What PEVARYL 1% cream contains
- The active substance is :
Deconazole nitrate............................................................................................................ 1.0 g
per 100 g of cream.
- Other ingredients are :
Ethylene glycol stearates and macrogols 300 and 1500 (Tefose 63), liquid kerosene, unsaturated polyglycolysed glycerides (Labrafil M 1944 CS), benzoic acid, butylated hydroxyanisole (E320), purified water.
What PEVARYL 1% cream is and what it contains
This medicine comes in the form of a cream. Tube of 30 g.
Marketing authorization holder
KARO PHARMA AKTIEBOLAG
BOX 16184
103 24 STOCKHOLM
SWEDEN
Marketing authorization holder
ALLOGA FRANCE
ZAC DE CHAPOTIN SUD
69970 CHAPONNAY
Manufacturer
LUSOMEDICAMENTA - SOCIEDADE TECNICA FARMACEUTICA, S.A.
ESTRADA CONSIGLIERI PEDROSO 69 B, QUELUZ DE BAIXO,
2730-055 BARCARENA,
PORTUGAL.
Product names in member states of the European Economic Area
Not applicable.
The last date on which this leaflet was revised was :
November 2021
Other
Detailed information on this drug is available on the ANSM (France) website.